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Evaluation of the efficacy of curcuma drug in comparison with meloxicam on pain relief and functional improvement of patients with knee osteoarthritis

Protocol summary

Study aim
Determining the effectiveness of Curcuma Longa oral drug in comparison with meloxicam oral drug in reducing pain and improving performance patients with knee osteoarthritis
Design
randomized clinical trial, comparison of two arm parallel, double blinded, randomized on 60 patients in phase 3 blocked and cluster random method is used
Settings and conduct
study will be on patient of rehabilitation clinics and sort them in two groups and after filling the consent form it will be started ,intervention group will take two tablet of curcuma daily and control group will take 1 meloxicam daily
Participants/Inclusion and exclusion criteria
Inclusion criteria : completing a consent form, having symptoms of knee osteoarthritis in at least one recent month, age between 40 and 60, lack of the presence of any other disease around the affected limb. Exclusion criteria: having diabetes, having diseases such as Rheumatism, gout, collagen vascular and lupus, very severe osteoarthritis of the knee based on radiology, having accompanying radiculopathy, having brucella, BMI above 42, history of trauma, fracture and injury to the affected joint, nerve damage and neuropathies, inability to communicating and completing questionnaires, history of knee replacement on the affected side, history of allergies to drugs used in the study, history of significant heart, kidney, liver and lung disorders, pregnant and lactating women, history of injection in the affected joint or in addition in the last 3 months , patients taking anticoagulants, cancer patients, history or gastrointestinal disorders and stomach problems, consuming warfarin and ticlopidine and aspirin, uncontrolled hypertension.
Intervention groups
1 group will take two curcuma tablets daily for 1 month 2 group will take 15 mg of meloxicam daily for 10 days
Main outcome variables
pain , knee dysfunction , morning stiffness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220513054837N1
Registration date: 2022-09-03, 1401/06/12
Registration timing: registered_while_recruiting

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Alireza Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 9719
Email address
dralirezakarimi1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-28, 1401/06/06
Expected recruitment end date
2023-02-25, 1401/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of curcuma drug in comparison with meloxicam on pain relief and functional improvement of patients with knee osteoarthritis
Public title
comparison of curcuma with meloxicam in knee osteoarthritis pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
completing and signing a consent form having symptoms of knee osteoarthritis in at least one recent month age between 40 and 60 lack of the presence of any other disease around the affected limb
Exclusion criteria:
having diabetes having diseases such as Rheumatism, gout, collagen vascular and lupus having accompanying radiculopathy history of trauma, fracture and injury to the affected joint, nerve damage and neuropathies history of knee replacement on the affected side history of allergies to drugs used in the study history of significant heart, kidney, liver and lung disorders pregnant and lactating women BMI above 42 having brucellosis history of injection in the affected joint or in addition in the last 3 months inability to communicating and completing questionnaires patients taking anticoagulants cancer patients history or gastrointestinal disorders and stomach problems consuming warfarin and ticlopidine and aspirin uncontrolled hypertension very severe osteoarthritis of the knee based on radiology
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To make the study random, the blocked and cluster random method is used. Patients also in terms of age and the severity of the symptoms of the disease is divided into categories. The list will be prepared by a computer with the same block length and the secretary of the clinic divides patients based on the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of the study is that the statistical expert and the questioner will not know the prescribed Medications to patients, but patients will not be blind in this study. For each patient to separately, first the cause and then the stages of research and the drugs used and their side effects will be explained and a written letter of satisfaction is taken.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No.13, 16 meter Fire station Ave.,tatkt jamshid cross road, Aboonasr Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7157763434
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.SUMS.MED.REC.1401.086

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M19.90
ICD-10 code description
Unspecified osteoarthritis, unspecified site

Primary outcomes

1

Description
Pain rate based on the score obtained from the Visual Analog Scale questionnaire in the study
Timepoint
before and after starting treatment in second , forth and fifth weeks
Method of measurement
Filling in the questionnaire VAS by the patient and reading the questionnaire information

2

Description
knee disability based on the score obtained from the Oxford knee Scale in the study
Timepoint
before and after starting treatment in second , forth and fifth weeks
Method of measurement
Filling in the questionnaire OKS by the patient and reading the questionnaire information

3

Description
Morning stiffness based on the score obtained from the Western Ontario and McMaster Universities Arthritis Index in the study
Timepoint
before and after starting treatment in second , forth and fifth weeks
Method of measurement
Filling in the questionnaire WOMAC by the patient and reading the questionnaire information

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1, Treatment in group 1 includes taking 15 mg of meloxicam orally daily for ten days and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting.
Category
Treatment - Drugs

2

Description
Intervention group: 2, treatment in group 2 will include two turmeric tablets (curcuma longa ) (turmeric extract) daily for one month, each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract and patients will be taught the method of correcting the way of life and Omeprazole will be prescribed also if needed so they take it fasting.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Imam Reza Rehabilitation Clinic
Full name of responsible person
Mani Ramzi
Street address
Emam Reza Clinic , Namazi Square
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7700
Email
motahari@sums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Seyed Ali Hashemi
Street address
Shahid Chamran Hospital,Shahid Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
71948-15644
Phone
+98 71 3624 0101
Email
chamhosp@sums.ac.ir

3

Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Amir Reza Mesbahi
Street address
Rajaee Hospital, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
In cross of Moaref Educational Institutions, Khalili Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Reza Karimi
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.13,16 Meter Firestation Ave., Takhtjamshid Crossroad, Shiraz
City
Shiraz
Province
Fars
Postal code
71577-63434
Phone
+98 71 3720 9719
Email
dralirezakarimi1988@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Reza Karimi
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.13,16 Meter Firestation Ave., Takhtjamshid Crossroad, Shiraz
City
Shiraz
Province
Fars
Postal code
71577-63434
Phone
+98 71 3720 9719
Email
dralirezakarimi1988@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Reza Karimi
Position
Medical Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.13,16 Meter Firestation Ave., Takhtjamshid Crossroad, Shiraz
City
Shiraz
Province
Fars
Postal code
71577-63434
Phone
+98 71 3720 9719
Email
dralirezakarimi1988@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all existing data will be reachable after making people unidentifiable
When the data will become available and for how long
starting access period one year after publish
To whom data/document is available
all personal
Under which criteria data/document could be used
if data from this study could help improve sciences trend .
From where data/document is obtainable
alireza karimi 09015613559
What processes are involved for a request to access data/document
after sending request , a call will be made with cooperative personal and if there are no disagreement , requesting data will be send to them in 4 weeks period .
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